1. Field of the Invention
This invention relates to the field of medical equipment, and more particularly to a device, which can hold any and all components involved in the insertion of an intravenous cannula into a patient's vein and allow the subsequent administration of drugs or fluids into an intravenous administration set, whereby the risks and associated dangers of health care worker laceration and needle stick injury during the recapping of hypodermic or cannulae needles, the opening of ampules or administration of drugs from syringes, directly or via hypodermic needle into intravenous tubing, are eliminated by enabling a single handed process.
2. Description of the Prior Art
The prior art teaches a variety of storage racks, storage trays, and organizing devices which facilitate neat, convenient storage and holding containers for various medical devices, needle syringe assemblies and other medical and non-medical tools. The prior art addresses the need for providing convenient access to the equipment during a medical procedure. The prior art also addresses a device which carries needles in such a manner, that the medical personnel are spatially protected from directly contacting the needle itself, and therefore, reducing the possibility of being punctured with a contaminated needle during a medical procedure, as a contaminated needle may carry a contagious disease, such as the AIDS virus.
Examples of the prior art are found in U.S. Pat. Nos. 2,659,485, 2,974,804, 4,023,757, 4,049,126, 4,411,868, 4,658,957, 4,844,249, 4,846,803, 4,875,583, 4,911,083, 4,921,199, 4,951,685, 4,966,582, 4,973,315, 5,069,666, 5,156,426 and 5,099,992. The prior art describes different variations of utility trays and or containers, which have needle and/or syringe holders and may have other compartments for storing and/or transporting a plurality of used and/or unused syringes, alcohol wipes, and/or vials of medication, and the like. Most of these devices of the prior art deal with needles and the danger of needlestick injury only in regard to the recapping process of the contaminated needle and after completion of a singular injection or blood withdrawal using one syringe-needle assembly. Among these devices is the medical supplies container, subject of U.S. Pat. No. 4,844,249 granted to Coulombe et Al., which is a hand-held transport container and can provide for physical separation of a restraining hand from the needle cap during recapping, reducing the danger of needlestick.
Further is the Needle Guard, subject of U.S. Pat. No. 5,156,426 granted to Graves, which is a hand held instrument with holes to accommodate syringe caps and slots to accept Y-ports, having a design to allow the injection from a singular syringe into only latex ports of the Y-port type. Similarly, Sit et Al. describe in U.S. Pat. No. 4,966,582 a device which will accept only ports of the latex Y-port type and allow injections from syringes and recapping to occur using two hands. Another device as described by Gericke in U.S. Pat. No 5,069,666 also allows for the restraint of a port of the latex Y-port type only, within a hand held device, which allows the bimanual insertion of a singular syringe-needle unit into the port and recapping of the needle to occur with only a relative degree of protection from needlestick injury. It will further alternately restrain and secure in place up to three secondary intravenous tubings within the latex port.
Villaveces describes a device in U.S. Pat. No. 4,921,199 which serves to restrain a transcutaneous cannula for intravenous placement by its protective cap and in a fashion to allow single handed removal of the unit from the cap. There is also a small c-clamp appendage to hold the end of the intravenous tubing in ready for connection to the cannula after the cannula has been inserted into the patient's vein. An associated disposable styrofoam block is described, which serves to receive the needle after placement of the plastic cannula into the vein, so as to facilitate subsequent connection of the intravenous tubing to the cannula and fixation to the patient.
Heimried describes a device in U.S. Pat. No. 5,099,992, which organizes syringes containing drugs with the associated and respective drug vials on a common block to provide sterile restraint of syringes without needles for convenient and aseptic use. While all of these examples of prior art provide some manner of protection and/or benefit to the user in situations of very narrow scope, they fail to comprehensively address the multiple and very critical issues pertinent to intravenous therapy in the setting of anesthesia in the 1990's: Foremost, needlesticks occur because the opposing hand is placed in front of the needle and because considerable force is often required to pierce a latex membrane. Needles remain an integral component in intravenous drug administration. During anesthesia, multiple injections should be completed and preferably using one hand only, to effectively eliminate and not simply reduce needlestick risk, as well as to allow for simultaneous and continuous maintenance of the patient's airway during injections. It is also necessary to maintain strict asepsis of all intravenous components over a period of hours, as typically numerous incremental doses of drugs from the multiple syringes are administered to meet the patient's needs as they occur throughout the anesthetic. There is a need to organize a multiplicity of syringes of different types and manufacture, aseptically near the patient, the anesthetist and together with the injection ports in a manner to accommodate the needle and sheath assemblies of all types and sources of manufacture on a completely reusable device.
The introduction of hooded needles into medical practice requires that the latex ports be restrained by a device in a fashion to allow free access to the whole circumference of the latex membrane of the Y-port. This will allow entry with hooded needles, while providing protection from standard hypodermic needles and, at the same time, the port need not be removed from the protective device, when such hooded needles are utilized for injections. The close proximity of the aseptic latex port membrane to the restraining surfaces themselves contribute to needle contamination and this proximity should be avoided. Only one hand should be utilized throughout the injection process to eliminate exposure of an opposing hand to unsheathed needles. A reusable device should maintain aseptic surfaces of intravenous therapy components distant from non-sterile surfaces of the device itself, to prevent contamination of aseptic surfaces which are positioned and reused during anesthesia. Such a design will allow the device to be utilized and reused while observing only standard aseptic techniques. Safety devices are avoided when associated user inconvenience results. The device should simplify the procedure and be easy to use to ensure high user compliance.
It is the object of the present invention to provide a work area which will restrain, fixed in space, all and any intravenous components in common use, in a generic fashion being independent of type or manufacture. Needles, syringes, injection ports, sharp ampule fragments, intravenous tubings and transcutaneous cannulae are restrained by the external and typically contaminated surfaces of the ports, tubings or needle caps, as to allow single handed fracture of ampules, drug injection and recapping of needles in a safe and aseptic fashion. Because only one hand is used and remains behind the needle at all times, the possibility of needlestick injury is effectively eliminated and not merely reduced, as would occur by merely placing the opposing hand at a distance from the exposed needles as per prior art methodologies. This single handed technique will allow simultaneous control of the patient airway during the injection process and facilitate insertion of transcutaneous cannulae. The device will be reusable in its entirety, durable and readily mounted onto any intravenous pole at a height and location convenient to the anesthetist and will function without requiring the utilization of any additional or special disposable items. It will restrain tubings and needles in a state of readiness for insertion into the vein or during use thereafter, will allow ampules to be opened using a single hand and without laceration injury and will further facilitate the maintenance of aseptic surfaces in an aseptic state. Ports will be restrained to allow syringes or secondary infusions to remained connected directly or via needle, without danger of these syringes or infusions becoming displaced or leading to their contamination or puncture of attending personnel's skin.
Above all, the use of such a device must allow compliance with the requirements of the Occupational Safety and Health Administration's safety guidelines for health care professionals, without creating significant new difficulties for the user. The device must be simple to use/understand and require little or no training to use effectively/safely. The device should reduce work and increase safety regarding the completion of I.V. injections, and particularly those injections utilizing needles, into intravenous tubing and injection ports of any and all types and from any manufacturer. As a device designed for the setting of anesthesia, there remains a need for a device which, in a generic fashion accepts all commonly encountered intravenous paraphernalia, organizes multiple drug filled syringes together with an adequate number of injection ports, facilitates multiple injections and allows them to occur serially and with only one hand. The reusable device should mount easily and securely for use onto intravenous poles commonly used to suspend intravenous solutions and to provide continuous availability in the operating room, while allowing for convenient removal for cleaning, should gross contamination occur.